ObesityALANCT01355952
An Open-Label Pilot Trial of Alpha Lipoic Acid (ALA) for Weight Loss in Schizophrenia
A study testing Alpha Lipoic Acid in people with Obesity and Weight Loss, run by Yale University at 1 site in United States.
Trial summary
The aim of this study is to collect pilot data to compare the effectiveness of treatment with Alpha Lipoic Acid (ALA) for reduction in body weight in 40 obese outpatients with schizophrenia or schizoaffective disorder in an open-label pilot trial. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Weight Loss, Schizophrenia
- What is being tested?
- Alpha Lipoic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years;
- Meet DSM-IV criteria for schizophrenia or schizoaffective disorder (confirmed from clinical chart)
- Overweight, as defined with a BMI of equal to or greater than 27 kg/m²;
- Be on a stable dose of antipsychotic medication; i.e. at least one month with no dosage change, and two months from an antipsychotic switch;
- Deemed to be symptomatically stable by the clinical staff in the last two months;
- 8) English speaking
Who cannot join
- A history of dementia, mental retardation or other neurological disorder that may interfere with study ratings;
- Not capable of giving informed consent for participation in this study;
- Ongoing pregnancy;
- A medical disorder that is known to cause obesity
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Mental Health Center
New Haven, Connecticut, 06519
About this study
The aim of this study is to collect pilot data to compare the effectiveness of treatment with Alpha Lipoic Acid (ALA) for reduction in body weight in 40 obese outpatients with schizophrenia or schizoaffective disorder in an open-label pilot trial. The investigators also plan to test the feasibility of utilizing ALA as a weight loss agent for obese outpatients with schizophrenia or schizoaffective disorder in terms of tolerability, schizophrenia symptoms, cognition and side effects. We have run a total of 12 non-diabetic participants and are now recruiting diabetic patients in hopes of comparing the two groups.
Read the detailed description
Design: This is a ten week open-label, fixed dose clinical study of alpha lipoic acid (ALA) for the treatment of antipsychotic weight gain in outpatients with schizophrenia or schizoaffective disorder.
Study Endpoints: The primary outcome measure is change in body weight from baseline. Secondary outcome measures are fasting serum glucose, glycosylated hemoglobin, insulin, LDL cholesterol, triglyceride levels, quality of life (Q-LES-Q), Clinical Global Impression (CGI) scores and performance on the The Brief Assessment of Cognition in Schizophrenia neurocognitive battery (BACS). (after preliminary analysis, we have changed the cognitive assessment to the DSST task only. The investigators are also going to conduct exploratory analyses of food craving, food preference and food frequency.
Subjects: Subjects will be recruited from the Psychosis Program and clinician referrals from other teams at the CMHC. Based on our previous weight loss studies the investigators expect very high enthusiasm from the subjects.
Procedure and assessment schedule: Subjects who meet the inclusion/exclusion criteria will participate in a multi-step screening process where demographic information will be gathered, weight and BMI will be measured and fasting blood will be taken, and if you are a female, a urine sample will be tested for pregnancy. If lab results are adequate, the subject will continue on to a baseline visit where they will start taking alpha lipoic acid (ALA) at 600mg three times a day (1800mg total) for a total of ten weeks. At each visit, weight will be obtained, scheduled blood will be drawn and study ratings will be conducted. A short visit with the physician every two weeks ensures safety and improves rating fidelity. Medication compliance will be ensured with pill counts, feedback and encouragement that is standard for clinical trials with schizophrenia patients. Research scales are standard schizophrenia and food scales.
- Conditions
- Obesity, Weight Loss, Schizophrenia
- Being tested
- Alpha Lipoic Acid
- Keywords
- Obesity, Weight Loss, Schizophrenia, Alpha Lipoic Acid
- Medical subject headings
- Obesity, Weight Loss, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha Lipoic AcidDietary supplement
600mg three times per day (1800mg total) daily for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Alpha Lipoic Acid | Experimental | taking 1800mg daily (600mg 3 times per day) Alpha Lipoic Acid (ALA) open-label for 10 weeks. Receives: Dietary Supplement: Alpha Lipoic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
change in body weight from baseline
Measured: week 10
Secondary outcomes (2)
Change in lab values
change in fasting serum glucose, glycosylated hemoglobin, insulin, LDL cholesterol, triglyceride levels from baseline to week 10
Measured: week 10
Change in ratings of quality of life and cognition
change in quality of life (Q-LES-Q), Clinical Global Impression (CGI) scores and performance on the The Brief Assessment of Cognition in Schizophrenia neurocognitive battery (BACS).
Measured: week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cenk Tek, Yale University
- Investigators
- Cenk Tek, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355952
- Sponsor's protocol ID
- 1103008158
- Acronym
- ALA
- Status last verified
- Nov 2015
- First submitted
- 16 May 2011
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ratliff JC, Palmese LB, Reutenauer EL, Tek C. An open-label pilot trial of alpha-lipoic acid for weight loss in patients with schizophrenia without diabetes. Clin Schizophr Relat Psychoses. 2015 Jan;8(4):196-200.
PubMed 23471087
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Pilot Trial of Alpha Lipoic Acid (ALA) for Weight Loss in Schizophrenia
- ClinicalTrials.gov ID
- NCT01355952
- Acronym / sponsor ID
- ALA / 1103008158
- Conditions
- Obesity, Weight Loss, Schizophrenia
- Keywords
- Obesity, Weight Loss, Schizophrenia, Alpha Lipoic Acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to collect pilot data to compare the effectiveness of treatment with Alpha Lipoic Acid (ALA) for reduction in body weight in 40 obese outpatients with schizophrenia or schizoaffective disorder in an open-label pilot trial. The investigators also plan to test the feasibility of utilizing ALA as a weight loss agent for obese outpatients with schizophrenia or schizoaffective disorder in terms of tolerability, schizophrenia symptoms, cognition and side effects. We have run a total of 12 non-diabetic participants and are now recruiting diabetic patients in hopes of comparing the two groups.
Detailed description
Design: This is a ten week open-label, fixed dose clinical study of alpha lipoic acid (ALA) for the treatment of antipsychotic weight gain in outpatients with schizophrenia or schizoaffective disorder.
Study Endpoints: The primary outcome measure is change in body weight from baseline. Secondary outcome measures are fasting serum glucose, glycosylated hemoglobin, insulin, LDL cholesterol, triglyceride levels, quality of life (Q-LES-Q), Clinical Global Impression (CGI) scores and performance on the The Brief Assessment of Cognition in Schizophrenia neurocognitive battery (BACS). (after preliminary analysis, we have changed the cognitive assessment to the DSST task only. The investigators are also going to conduct exploratory analyses of food craving, food preference and food frequency.
Subjects: Subjects will be recruited from the Psychosis Program and clinician referrals from other teams at the CMHC. Based on our previous weight loss studies the investigators expect very high enthusiasm from the subjects.
Procedure and assessment schedule: Subjects who meet the inclusion/exclusion criteria will participate in a multi-step screening process where demographic information will be gathered, weight and BMI will be measured and fasting blood will be taken, and if you are a female, a urine sample will be tested for pregnancy. If lab results are adequate, the subject will continue on to a baseline visit where they will start taking alpha lipoic acid (ALA) at 600mg three times a day (1800mg total) for a total of ten weeks. At each visit, weight will be obtained, scheduled blood will be drawn and study ratings will be conducted. A short visit with the physician every two weeks ensures safety and improves rating fidelity. Medication compliance will be ensured with pill counts, feedback and encouragement that is standard for clinical trials with schizophrenia patients. Research scales are standard schizophrenia and food scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alpha Lipoic Acid | Experimental | Dietary Supplement: Alpha Lipoic Acidtaking 1800mg daily (600mg 3 times per day) Alpha Lipoic Acid (ALA) open-label for 10 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 to 70 years;
- Meet DSM-IV criteria for schizophrenia or schizoaffective disorder (confirmed from clinical chart)
- Overweight, as defined with a BMI of equal to or greater than 27 kg/m²;
- Be on a stable dose of antipsychotic medication; i.e. at least one month with no dosage change, and two months from an antipsychotic switch;
- Deemed to be symptomatically stable by the clinical staff in the last two months;
Key exclusion criteria (4 listed)
- A history of dementia, mental retardation or other neurological disorder that may interfere with study ratings;
- Not capable of giving informed consent for participation in this study;
- Ongoing pregnancy;
- A medical disorder that is known to cause obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha Lipoic Acid600mg three times per day (1800mg total) daily for 10 weeks | Dietary supplement | Alpha Lipoic Acid |
Primary outcome
Change in Body Weight
Time frame: week 10
change in body weight from baseline
2 secondary outcomes
Change in lab values
Time frame: week 10
Change in ratings of quality of life and cognition
Time frame: week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2015.
- Derived from this study: PubMed 23471087Ratliff JC, Palmese LB, Reutenauer EL, Tek C. An open-label pilot trial of alpha-lipoic acid for weight loss in patients with schizophrenia without diabetes. Clin Schizophr Relat Psychoses. 2015 Jan;8(4):196-200.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cenk Tek, M.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha Lipoic Acid in people with Obesity and Weight Loss, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (time frame: week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01355952, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2015.